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FDA okays Amarin’s Vascepa for cardiovascular risk reduction

Drug is on course for blockbuster sales


Amarin has been given an early Christmas present by the FDA – the approval of its fish oil-derived drug Vascepa to reduce the risk of cardiovascular events in high-risk patients. 

The expanded approval for Amarin’s only marketed product was odds on after an FDA advisory committee voted unanimously in favour of the drug last month, but it came a little earlier-than-expected and sparked another leap in the Ireland-domiciled firm’s already buoyant share price in after-hours trading.

Vascepa (icosapent ethyl) becomes the first FDA-approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors.

The approval is based on the results of the REDUCE-IT trial, which evaluated Vascepa in more than 8,000 statin-treated adults with elevated cardiovascular risk. It achieved a reduction of 25% in major adverse cardiovascular events (MACE) and a 20% reduction in deaths.

It’s also a remarkable achievement as generics of GlaxoSmithKline’s rival fish oil therapy Lovaza (omega-3-acid ethyl esters capsules) were unable to show a similar cardiovascular benefit in the large-scale ASCEND trial reported last year.

Amarin’s drug has been approved since 2012 to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, but the new indication makes the drug an option for many millions of US patients rather than a few hundred thousand – and sets it on course for blockbuster sales.

Crucially, the FDA’s approved label includes both the full range of patients in the REDUCE-IT trial, including lower-risk patients – those who have not had a CV event but are at risk of having one – as well as for secondary prevention in those who have already suffered a CV event.

An attempt to extend its use into combination therapy with statins was rejected by an FDA panel in 2013 on the grounds that it wanted to see the REDUCE-IT data first.

Amarin recorded $287m in Vascepa sales in the first nine months of this year, and with the new approval in hand says it will make $410m to $425m for the full-year rising to $659m to $700m in 2020, helped by a doubling in its sales force to 800 reps.

Analysts at Jefferies have previously said that approval based on the REDUCE-IT data could catapult Vascepa into $2bn-plus sales territory.

The FDA approval will likely also drive continued speculation that it may become a takeover target for a big biopharma company – with Amgen, Pfizer and Novartis mentioned most frequently in dispatches – although the latter’s recent $7bn deal to buy The Medicine Company makes it a less likely option.

Article by
Phil Taylor

16th December 2019

From: Regulatory



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